- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07558889
The Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population (ENDOCancerDATA)
The ENDOCancer-DATA: the Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Endometrial cancer represents the most common gynecological cancer in industrialized countries and the fourth most common neoplasm after breast, lung and colorectal cancer. Unlike other neoplasms, its incidence and mortality are continuously increasing. In this context, the National Health System requires an optimization of the diagnosis and treatment strategies of this carcinoma. This aspect leads a continuous effort to improve to properly manage the impact that this disease has on female health in Italy. Throughout the world, there are national, supranational models and registers aimed at establishing and managing over time an archive of all newly diagnosed cancer cases, ensuring that data recording takes place in a rigorous, continuous and systematic manner. An excellent example of this is the SEER of the National Cancer Institute of America, which has the task of recording and monitoring the epidemiological-clinical data of various carcinomas, to monitor the clinical progress and management of therapeutic programs of neoplastic pathologies. This program represents the epidemiological and statistical basis of important scientific evidence, both prospective and retrospective, aimed at reporting and demonstrating the effectiveness of preventive, diagnostic and therapeutic approaches in the various oncological pathologies examined.
On these premises, the aim of this study is to lay the bases for an ambitious project that reports and records all the epidemiological-clinical information of the cases of endometrial carcinoma diagnosed and treated in the reference oncology centers involved on the national territory, to create a process of analysis of the data
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Francesco Fanfani, MD
- Telefonnummer: +390630133421
- E-post: francesco.fanfani@policlinicogemelli.it
Studiesteder
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Roma, Italia, 00136
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
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Ta kontakt med:
- Francesco Fanfani, MD
- Telefonnummer: 0630153421
- E-post: francesco.fanfani@policlinicogemelli.it
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
All patients undergoing staging and cytoreduction surgery for endometrial cancer will be included in the study.
This database will make use of data collected retrospectively with prospectively continuously updated prognostic and clinical information.
The following data will be collected: clinical characteristics (age, BMI, ASA, previous tumors), histopathological data (histotype, grade, FIGO stage, etc.) Furthermore, data will be collected relating to the adjuvant chemotherapy or radiotherapy treatment performed, survival outcome (DFS and OS), number of relapses and deaths, type of relapse, treatment at relapse, cause of death.
Beskrivelse
Inclusion Criteria:
- diagnosis of endometrial cancer (stage I-IV, G1-3, and special histotypes)
- age > 18 years
- American Society of Anesthesiologists classification (ASA score) 1-3
- patients undergoing staging, cytoreduction or diagnostic surgery with acquisition of histological examination on which IHC and/or NGS studies have been performed for the molecular profile of the carcinoma
- Signed informed consent
Exclusion Criteria:
- patients with missing information
- patients not treated in the participating centers for which only partial and fragmented information will be available
- molecular profile not known and\or not recoverable and retrospectively analysable
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Endometrial cancer patients
All patients undergoing staging and cytoreduction surgery for endometrial cancer
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Disease Free Survival
Tidsramme: Baseline.
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To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of DFS (Disease-Free Survival).
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Baseline.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival
Tidsramme: Baseline.
|
To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of OS (overall survival).
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Baseline.
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Francesco Fanfani, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Livmorsykdommer
- Kjønnssykdommer, kvinner
- Genitale neoplasmer, kvinnelige
- Uterine neoplasmer
- Endometriale neoplasmer
Andre studie-ID-numre
- 6168
Plan for individuelle deltakerdata (IPD)
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